Material Safety Data Sheet for Levalbuterol tartrate USP

Identification

Product Name: Levalbuterol tartrate
Synonyms: (R)-Albuterol tartrate, Xopenex (brand), Levosalbutamol tartrate
Chemical Family: Adrenergic beta-2 agonist
Manufacturer: Refer to label or packaging for supplier details
Emergency Phone Number: Refer to local poison control or manufacturer
Recommended Use: Pharmaceutical active, bronchodilator for respiratory relief
Restrictions on Use: For healthcare professional dispensing only, not for general public without prescription

Hazard Identification

Classification: Not classified as hazardous under OSHA Hazard Communication Standard (29 CFR 1910.1200)
GHS Label Elements: Not required
Main Hazards: May cause allergic reaction in sensitive people. Potential to trigger asthma-like symptoms, eye irritation, mild skin reaction. Not acutely toxic in small quantities. Large exposure can affect cardiac rhythm and muscle tremors in overdose situations.
Signal Word: Not required
Hazard Statements: Exposure to powder or solution may aggravate pre-existing pulmonary conditions.

Composition / Information on Ingredients

Chemical Name: Levalbuterol tartrate
Molecular Formula: C13H21NO3 · C4H6O6
Molecular Weight: 628.71 g/mol
Purity: > 98% (as typically provided by USP suppliers)
CAS Number: 138528-85-1
Other Ingredients: None in pure API form; finished products may contain excipients

First Aid Measures

Inhalation: Move to fresh air. If symptoms develop, seek medical help. Continuous coughing or difficulty breathing requires immediate medical attention.
Skin Contact: Wash exposed skin with plenty of soap and water. If irritation or allergic reaction persists, consult a doctor.
Eye Contact: Flush eyes for at least 15 minutes with water. Remove contact lenses if present and easy to do. Seek medical help if discomfort remains.
Ingestion: Rinse mouth with water. Do not induce vomiting. Seek medical care if large quantity swallowed or if symptoms like palpitations, tremor, or dizziness develop.
Advice to Physicians: Treat symptomatically, monitor vital signs and cardiac rhythm, consider beta-blockers if patient develops tachycardia after large exposure.

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, foam, dry chemical powder, or carbon dioxide for small fires.
Special Hazards: Burning material produces toxic gases such as nitrogen oxides, carbon monoxide, and carbon dioxide. Powder dust may pose minor explosion risk in confined space.
Protective Equipment: Firefighters use self-contained breathing apparatus and full protective gear. Limit exposure through open flames.
Specific Methods: Prevent runoff from firefighting to sewers and waterways, contain spill if possible.

Accidental Release Measures

Personal Precautions: Use gloves, lab coat, and N95 or higher mask. Limit inhalation, skin or eye exposure. Evacuate unnecessary personnel.
Environmental Precautions: Prevent entry to drains or surface water. Notify authorities for significant spills.
Clean-Up Method: Absorb dry powder or solution with inert material like sand, then sweep up. Wash area with mild detergent solution. Dispose in chemical waste container. Avoid generating dust.

Handling and Storage

Handling: Employ closed-system transfer or containment if powder is handled in quantity. Avoid breathing dust or vapor. Keep away from food, drink, and animal feed.
Storage: Store at 20-25°C (68-77°F), control humidity and direct sunlight. Keep container tightly closed. Secure from unauthorized use.
Conditions to Avoid: Heat, flame, and moisture may degrade active compound.

Exposure Controls and Personal Protection

Occupational Exposure Limit: Not established for Levalbuterol tartrate. Minimize dust generation as a precaution.
Engineering Controls: Use local exhaust or general ventilation to avoid airborne concentrations.
Personal Protective Equipment: Safety goggles, disposable gloves, lab coat. NIOSH-approved respirator if exposure exceeds minimal or in case of spill.
Additional Measures: Use good industrial hygiene, wash hands after handling. Remove contaminated clothing for professional cleaning or disposal.

Physical and Chemical Properties

Appearance: White or almost white crystalline powder
Odor: Odorless
Odor Threshold: Not established
pH: 4-5 (1% solution in water)
Melting Point: Decomposes > 196°C
Boiling Point: Not applicable
Solubility: Freely soluble in water, slightly soluble in ethanol
Vapor Pressure: Negligible
Relative Density: Not available
Partition Coefficient: Not determined
Other Properties: Stable as a solid under recommended transport and storage. Not volatile.

Stability and Reactivity

Chemical Stability: Chemically stable under normal handling and storage
Reactivity: No hazardous reactivity anticipated under normal conditions
Incompatibilities: Strong oxidizers, strong acids
Hazardous Decomposition Products: Acrid smoke, carbon monoxide, nitrogen oxides when heated to decomposition
Hazardous Polymerization: Will not occur

Toxicological Information

Routes of Exposure: Inhalation, skin absorption, ingestion
Acute Symptoms: Tremor, nervousness, palpitations, headache may occur with overdose/excess exposure
Target Organs: Heart, lungs, nervous system (due to beta-2 agonist activity)
Delayed/Chronic Effects: Risk of hypokalemia, tachycardia with prolonged large-scale exposure; rare allergic reactions (urticaria, angioedema)
Carcinogenicity: Not listed by IARC, NTP, ACGIH, or OSHA
Other Data: Extremely low toxicity by all routes in small quantities used clinically

Ecological Information

Aquatic Toxicity: No specific data, structurally similar compounds predicted low acute aquatic toxicity
Persistence and Degradability: Not persistent; expected to degrade by hydrolysis and microbial metabolism
Bioaccumulation: Low potential
Mobility in Soil: High solubility in water, moderate mobility predicted
Other Harmful Effects: No known significant environmental risk at therapeutic volumes; large uncontrolled discharges could harm aquatic organisms

Disposal Considerations

Disposal Methods: Collect all waste in sealed, labeled chemical waste containers. Incinerate at licensed facility or land fill according to national and local regulations.
Special Precautions: Do not flush to sewer. Dispose of empty packaging as regulated medical waste if contaminated.
Legal Requirement: Follow local, regional, and federal requirements for pharmaceutical chemical disposal

Transport Information

UN Number: Not regulated as hazardous for transport
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Special Precautions: Use tightly sealed original packaging. Avoid heat, shock, or damage during transit.
Labeling: Not subject to DOT, ICAO/IATA, IMDG regulations for transport of hazardous goods
Environmental Hazards: Not a marine pollutant

Regulatory Information

Occupational Safety and Health: Not subject to OSHA-specific chemical regulations. GHS labeling not required.
Inventory Listing: Check local chemical inventory for registration status.
WHMIS Classification (Canada): Not controlled
TSCA (USA): For research or pharmaceutical use only, not for general manufacturing
Other Regulations: Subject to prescription pharmaceutical controls under US FDA and other international authorities. Consult national authorities for workplace control recommendations and environmental reporting obligations.